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NCT06569186 | NOT YET RECRUITING | Infant, Very Low Birth Weight

Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Ariel A. Salas

Brief Summary:

In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.

Condition or disease

Infant, Very Low Birth Weight

Infant Development

Feeding Patterns

Intervention/treatment

Cue-based feedings

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 74 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 28 Weeks to 32 Weeks
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion criteria
  • * Birthweight \< 1500 grams
  • * Gestational age between 28 and 31 weeks of gestation
  • * Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
  • * Oral feeding initiated before 33 weeks PMA.
  • Exclusion criteria
    • * Major congenital/chromosomal anomalies,
    • * Patent ductus arteriosus causing significant cardiovascular symptoms
    • * History of necrotizing enterocolitis stage 2 or greater
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants

Location Details

NCT06569186

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How to Participate

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Locations

Not yet recruiting

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35233